510(k) · Cleared
ClearedPheron Peripheral Percutaneous Transluminal Angioplasty (Pta) Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotronik AG · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Oct 28, 2005 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Oct 28, 2005
- Review
- 28 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK052757 Pheron Peripheral Percutaneous Transluminal Angioplasty (Pta) CatheterBiotronik AG · 2005
- Descendant · cites it directly · 7 of its ownK072765 Passeo 18Biotronik, Inc. · 2007
- Descendant · cites it directly · 5 of its ownK082933 Passeo-35 Pta CatheterBiotronik, Inc. · 2008
- Descendant · 2 generations on · 3 of its ownK142379 Passeo-35 PTA CatheterBiotronik, Inc. · 2014
- Descendant · 3 generations on · 1 of its ownK222065 Passeo-35 Xeo Peripheral Dilatation CatheterBiotronik, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK151744 Passeo-18 Peripheral Dilation CatheterBiotronik, Inc. · 2015
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K072765Passeo 18Biotronik, Inc. · 2007 · cites it directly7descendants
- K082933Passeo-35 Pta CatheterBiotronik, Inc. · 2008 · cites it directly5descendants
- K142379Passeo-35 PTA CatheterBiotronik, Inc. · 2014 · 2 generations on3descendants
- K222065Passeo-35 Xeo Peripheral Dilatation CatheterBiotronik, Inc. · 2023 · 3 generations on1descendant
- K151744Passeo-18 Peripheral Dilation CatheterBiotronik, Inc. · 2015 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052757 | Pheron Peripheral Percutaneous Transluminal Angioplasty (Pta) Catheter | Biotronik AG | 2005 | — |
| +1 | K072765 | Passeo 18 | Biotronik, Inc. | 2007 | — |
| +1 | K082933 | Passeo-35 Pta Catheter | Biotronik, Inc. | 2008 | — |
| +2 | K142379 | Passeo-35 PTA Catheter | Biotronik, Inc. | 2014 | — |
| +3 | K222065 | Passeo-35 Xeo Peripheral Dilatation Catheter | Biotronik, Inc. | 2023 | — |
| +2 | K151744 | Passeo-18 Peripheral Dilation Catheter | Biotronik, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LIT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LIT device
- #1 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K072765 (Biotronik, Inc., 2007) has gone furthest, with 7 descendants of its own.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LIT
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LIT
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LIT
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LIT
2,073in 2025
MAUDE reports naming product code LIT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 64 | 0 | 577 |
| 2008 | 8 | 53 | 0 | 513 |
| 2009 | 7 | 29 | 2 | 623 |
| 2010 | 13 | 78 | 1 | 809 |
| 2011 | 10 | 82 | 0 | 857 |
| 2012 | 19 | 29 | 0 | 1,277 |
| 2013 | 14 | 79 | 2 (2) | 1,242 |
| 2014 | 12 | 90 | 3 | 1,178 |
| 2015 | 19 | 112 | 0 | 1,279 |
| 2016 | 11 | 116 | 1 | 1,529 |
| 2017 | 9 | 57 | 0 | 2,081 |
| 2018 | 6 | 118 | 2 | 2,188 |
| 2019 | 4 | 40 | 3 | 2,405 |
| 2020 | 9 | 125 | 0 | 2,443 |
| 2021 | 4 | 61 | 1 | 2,492 |
| 2022 | 8 | 122 | 0 | 2,155 |
| 2023 | 6 | 167 | 0 | 1,807 |
| 2024 | 6 | 43 | 2 | 1,913 |
| 2025 | 3 | 90 | 1 | 2,073 |
| 2026 | 4 | 205 | 0 | — |
https://510kreport.com/device/K052757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052757: Pheron Peripheral Percutaneous Transluminal Angioplasty (Pta) Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052757
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026